MedPath
FDA Approval

MAG 5 PT ROLL-ON PAIN RELIEF COOLING

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
RENU LABORATORIES, LLC
DUNS: 119451815
Effective Date
April 7, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Menthol(4.2 g in 84 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

RENU LABORATORIES, LLC

RENU LABORATORIES, LLC

119451815

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

MAG 5 PT ROLL-ON PAIN RELIEF COOLING

Product Details

NDC Product Code
76348-517
Application Number
M017
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
April 7, 2025
MAGNESIUM OROTATEInactive
Code: GI96W46M5AClass: IACT
LOBELIA INFLATAInactive
Code: 9PP1T3TC5UClass: IACT
MAGNESIUM SULFATEInactive
Code: DE08037SABClass: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9OClass: IACT
MAGNESIUM GLUCONATE ANHYDROUSInactive
Code: TH52F4317BClass: IACT
CANNABIS SATIVA SEED OILInactive
Code: 69VJ1LPN1SClass: IACT
CANNABIDIOLInactive
Code: 19GBJ60SN5Class: IACT
MENTHA PIPERITA (PEPPERMINT) OILInactive
Code: AV092KU4JHClass: IACT
MentholActive
Code: L7T10EIP3AClass: ACTIBQuantity: 4.2 g in 84 g
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
METHYLCELLULOSEInactive
Code: Z944H5SN0HClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
HAMAMELIS VIRGINIANA TOP WATERInactive
Code: NT00Y05A2VClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
MAGNESIUM MYRISTATEInactive
Code: Z1917F0578Class: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
© Copyright 2025. All Rights Reserved by MedPath
MAG 5 PT ROLL-ON PAIN RELIEF COOLING - FDA Approval | MedPath